[Federal Register Volume 84, Number 166 (Tuesday, August 27, 2019)]
[Rules and Regulations]
[Pages 44718-44725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18386]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0088; FRL-9997-10]


Emamectin Benzoate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
emamectin benzoate (referred to as emamectin in this document) in or on 
multiple commodities which are identified and discussed later in this 
document. Interregional Research Project No. 4 (IR-4) and Syngenta Crop 
Protection, LLC requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 27, 2019. Objections and 
requests for hearings must be received on or before October 28, 2019, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2018-0088, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

[[Page 44719]]

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2018-0088 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
October 28, 2019. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2018-0088, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of July 24, 2018 (83 FR 34968) (FRL-9980-
31), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
7E8644) by IR-4, IR-4 Project Headquarters, Rutgers, The State 
University of New Jersey, 500 College Road East, Suite 201W, Princeton, 
NJ 08540. The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of emamectin, including its 
metabolites and degradates in or on the raw agricultural commodities: 
Artichoke, globe at 0.06 parts per million (ppm), Brassica, leafy 
greens, subgroup 4-16B at 0.050 ppm, Celtuce at 0.100 ppm, Cherry 
subgroup 12-12A at 0.10 ppm, Fennel, Florence at 0.100 ppm, Fruit, 
pome, group 11-10 at 0.025 ppm, Herb subgroup 19A at 0.50 ppm, Kohlrabi 
at 0.050 ppm, Leafy greens subgroup 4-16A at 0.100 ppm, Leaf petiole 
vegetable subgroup 22B at 0.100 ppm, Nut, tree, group 14-12 at 0.02 
ppm, Vegetable, brassica, head and stem, group 5-16 at 0.050 ppm, and 
Vegetable, fruiting, group 8-10 at 0.020 ppm. The petition also 
proposed to amend 40 CFR 180.505 by removing the tolerances for 
residues of emamectin, including its metabolites and degradates, in or 
on the raw agricultural commodities: Fruit, pome, group 11 at 0.025 
ppm, Nut, tree, group 14 at 0.02 ppm, Pistachio at 0.02 ppm, Turnip, 
greens at 0.050 ppm, Vegetable, leafy, except brassica, group 4 at 
0.100 ppm, Vegetable, brassica, leafy, group 5 at 0.050 ppm, and 
Vegetable fruiting, group 8 at 0.020 ppm.
    That document referenced a summary of the petition prepared by 
Syngenta, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    In the Federal Register of August 24, 2018 (83 FR 42818) (FRL-9982-
37), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
7F8640) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, 
NC 27419-8300. The petition requested that 40 CFR part 180 be amended 
by establishing a tolerance for residues of emamectin, including its 
metabolites and degradates in or on vegetable, cucurbit, group 9 at 
0.03 ppm. That document referenced a summary of the petition prepared 
by Syngenta, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA is 
establishing tolerances that vary from what the petitioner requested, 
as authorized under FFDCA section 408(d)(4)(A)(i). EPA's explanation 
for those variations are contained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for emamectin including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with emamectin follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The main target organ for emamectin is the nervous system; 
treatment-related clinical signs (tremors, ptosis, ataxia, mydriasis, 
and hunched posture) and neuropathology (neuronal degeneration in the 
brain and in peripheral nerves and muscle fiber degeneration) were 
found in most of the emamectin studies in rats, dogs, rabbits, and 
mice. Decreased body weight was also a frequent finding.
    Integral to the dose-response assessment in mammals for this class 
of compounds is the role of P-glycoprotein (P-gp) in target tissues. P-
gp is a member of the adenosine triphosphate (ATP)

[[Page 44720]]

binding cassette transporter protein class/group, which reside in the 
plasma membrane and function as a transmembrane efflux pump, moving 
xenobiotics from the intracellular to the extracellular domain. P-gp is 
found in the canalicular surface of hepatocytes, the apical surface of 
proximal tubular cells in the kidneys, brush border surface of 
enterocytes, luminal surface of blood capillaries of the brain (blood 
brain barrier), placenta, ovaries, and the testes. As an efflux 
transporter, P-gp acts as a protective barrier to keep xenobiotics out 
of the body by excreting them into bile, urine, and intestinal lumen, 
and prevents accumulation of these compounds in the brain and gonads, 
as well as in the fetus. Therefore, test animals with genetic 
polymorphisms that compromise P-gp expression are particularly 
susceptible to emamectin and abamectin induced neurotoxicity.
    In this connection, some CF-1 mice have a polymorphism for the gene 
encoding P-gp and are either devoid (homozygous) or have diminished 
(heterozygous) levels of P-gp. These mice are found to be uniquely 
sensitive to the neurotoxic effects of emamectin and abamectin. In 
addition, the neonatal rat is also particularly sensitive to emamectin 
and abamectin as P-gp is undetectable in the neonatal rat brain. The 
first detection of P-gp is on post-natal day (PND) 7 and does not reach 
adult levels until approximately PND 28. As shown in the reproductive 
and DNT studies, neonatal rats are sensitive to the effects of 
abamectin-induced pup body weight reductions and death. In contrast, in 
the developing human fetus, the presence of P-gp was found as early as 
22 weeks of gestation. Based on the difference in the ontogeny of P-gp 
in neonatal rats and human newborns, the Agency does not believe that 
the early post-natal findings in the rat are relevant to human newborns 
or young children, at this time.
    The human multidrug resistance (MDR-1) gene encoding P-gp and 
polymorphism of MDR-1 gene are well studied. The literature data are 
inconclusive with respect to the functional significance of the genetic 
variance in P-gp in humans. Currently, the reported cases of 
polymorphism of the MDR-1 gene in human populations have not been shown 
to result in a loss of P-gp function similar to that found in CF-1 
mice. Given the ontogeny of P-gp and the lack of convincing evidence 
from the literature on human polymorphism of MDR-1 gene resulting in 
diminished P-gp function, the Agency considers the results of the 
studies with CF-1 mice not relevant for human health risk assessment. 
Therefore, the Agency is using results from toxicological studies 
conducted in the species that do not have diminished P-gp function for 
selecting toxicity endpoints and PODs for risk assessment. Among the 
test animals with fully functional P-gp, the beagle dog is the most 
sensitive species.
    Emamectin did not elicit increased fetal sensitivity in 
developmental toxicity studies in rats and rabbits. In the reproductive 
toxicity study, emamectin produced neuronal degeneration in the brain 
and spinal in parental and offspring animals at similar dose level (1.8 
mg/kg/day), and no increase in quantitative sensitivity was found in 
the pup with respect to the neurotoxicity. However, in the 
developmental neurotoxicity study in rats, there was an increase in 
both quantitative and qualitative sensitivity in the pups as no adverse 
effect was seen at the highest dose tested (3.6/2.5 mg/kg/day) in 
parental animals, while at 0.6 mg/kg/day, the pups showed a dose-
related decrease in open field motor activity at post-natal day 17. 
Body tremors, hind-limb extension, and auditory startle were also 
observed in the high dose pups (3.6/2.5 mg/kg/day).
    The carcinogenicity and mutagenicity studies provide no indication 
that emamectin is carcinogenic or mutagenic. Emamectin is classified as 
``not likely to be carcinogenic to humans.''
    Specific information on the studies received and the nature of the 
adverse effects caused by emamectin as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Emamectin (Emamectin 
Benzoate). Human Health Risk Assessment in Support of Establishing 
Permanent Tolerances on Globe Artichoke, Cherry Subgroup 12-12A, Herb 
Subgroup 19A, and Crop Group Conversions and Expansions to include Pome 
Fruit Group 11-10, Tree Nut Group 14-12, Brassica Vegetable Head and 
Stem Group 5-16, Brassica Leafy Greens Subgroup 4-16B, Leafy Greens 
Subgroup 4-16A, Leaf Petiole Vegetable Subgroup 22B, Fruiting Vegetable 
Group 8-10, and individual tolerances for Florence Fennel, Kohlrabi, 
Celtuce, and Cucurbit Vegetables Group 9'' on pages 42-48 in docket ID 
number EPA-HQ-OPP-2018-0088.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for emamectin used for 
human risk assessment is shown in Table 1 of this unit.

[[Page 44721]]



   Table 1--Summary of Toxicological Doses and Endpoints for Emamectin for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety  factors      risk assessment
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Dietary, all durations...........  NOAEL = 0.25 mg/kg/   Acute RfD = 0.0025   Subchronic and chronic oral
(General population including       day.                  mg/kg/day.           toxicity studies in dogs.
 infants and children).            UFA = 10x...........  aPAD = 0.0025 mg/kg/ Subchronic LOAEL = 0.5 mg/kg/day
                                   UFH = 10x...........   day.                 based skeletal muscle atrophy and
                                   FQPA SF = 1x........  Chronic RfD =         white matter multifocal
                                                          0.0025 mg/kg/day.    degeneration in the brains of
                                                         cPAD = 0.0025 mg/kg/  both sexes and white matter
                                                          day.                 multifocal degeneration in the
                                                                               spinal cords of males.
                                   ....................  ...................  Chronic LOAEL=0.5 mg/kg/day based
                                                                               on axonal degeneration in the
                                                                               pons, medulla, and peripheral
                                                                               nerves (sciatic, sural, and
                                                                               tibial); whole body tremors;
                                                                               stiffness of the hind legs,
                                                                               spinal cord axonal degeneration,
                                                                               and muscle fiber degeneration.
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: Not Likely to be carcinogenic to humans based on the absence
                                    of significant increase in tumor incidence in two adequate rodent
                                    carcinogenicity studies
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to emamectin, EPA considered exposure under the petitioned-for 
tolerances as well as all existing emamectin tolerances in 40 CFR 
180.505. EPA assessed dietary exposures from emamectin in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    Such effects were identified for emamectin. In estimating acute 
dietary exposure, EPA used 2003-2008 food consumption information from 
the U.S. Department of Agriculture's National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to 
residue levels in food, a refined acute assessment was conducted. The 
assessment relied upon percent crop treated (PCT) data, and a 
combination of monitoring data from the Pesticide Data Program (PDP) 
and field trial data. For hog meat, a tolerance level residue was 
assumed. For all other livestock commodities, anticipated residue 
values were used.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used 2003-2008 food consumption data from the USDA's 
NHANES/WWEIA. As to residue levels in food, a refined chronic 
assessment was conducted. The assessment relied upon the same data as 
above, except for using mean field trial data for cottonseed, tree 
nuts, globe artichoke, cherry subgroup 12-12A, and herb subgroup 19A.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that emamectin does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, and the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by FFDCA section 408(b)(2)(F), EPA may require registrants to submit 
data on PCT.
    The Agency estimated the PCT for existing uses as follows:
    Specific values used in the acute assessment for percent crop 
treated are: 10% almonds, 20% apples, 20% broccoli, 40% brussels 
sprouts, 25% cabbage, 20% cauliflower, 40% celery, 10% chicory, 2.5% 
cotton, 20% lettuce, 20% pears, 15% peppers, 2.5% pistachios, 10% 
spinach, 20% tomatoes, and 2.5% walnuts.
    Specific values used in the chronic assessment for percent crop 
treated are: 2.5% almonds, 10% apples, 5% broccoli, 20% brussels 
sprouts, 10% cabbage, 5% cauliflower, 20% celery, 5% chicory, 10% 
lettuce, 5% pears, 5% peppers, 2.5% pistachios, 5% spinach, 15% 
tomatoes, and 2.5% walnuts.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and California Department of 
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the 
chemical/crop combination for the most recent 10 years. EPA uses an 
average PCT for chronic dietary risk analysis and a maximum PCT for 
acute dietary risk analysis. The average PCT figures for each existing 
use is derived by combining available public and private market survey 
data for that use, averaging across all observations, and rounding up 
to the nearest 5%, except for those situations in which the average PCT 
is less than 1% or less than 2.5%. In those cases, the Agency would use

[[Page 44722]]

less than 1% or less than 2.5% as the average PCT value, respectively. 
The maximum PCT figure is the highest observed maximum value reported 
within the most recent 10 years of available public and private market 
survey data for the existing use and rounded up to the nearest multiple 
of 5%, except where the maximum PCT is less than 2.5%, in which case, 
the Agency uses less than 2.5% as the maximum PCT.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for emamectin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of emamectin. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide in Water Calculator (PWC), the estimated 
drinking water concentrations (EDWCs) of emamectin for acute exposures 
are estimated to be 1.5 parts per billion (ppb) for surface water and 
EDWCs for chronic exposures are estimated to be 1.15 ppb for surface 
water. No groundwater concentrations are predicted for emamectin, as 
the model (PRZM-GW; pesticide root zone model--groundwater) indicates 
emamectin will not break through into groundwater over the 100-year 
course of the modeled scenario.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute dietary risk 
assessment, the water concentration value of 1.5 ppb was used to assess 
the contribution to drinking water and for the chronic dietary risk 
assessment, the water concentration of value 1.15 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Residential exposures are not anticipated from the proposed uses of 
emamectin, nor are they anticipated from existing uses of emamectin 
since they are agricultural uses, restricted use products (i.e., 
restricted to use by certified applicators only), or are limited to 
non-residential areas (i.e., commercial and industrial areas) with the 
exception of a gel bait product. The ready-to-use (RTU) gel bait 
product is registered for use in multiple locations, including in 
residential areas. As the RTU product requires no mixing/loading, the 
only potential for residential handler exposure is via application. 
When applying this product according to use directions, bait points and 
bait beads are intended to be placed in cracks and crevices where 
direct contact by adults is anticipated to be negligible. Post-
application exposures for adults and children are also unlikely due to 
the nature of the application method, and the location of the bait 
placement. Therefore, a residential exposure assessment has not been 
conducted and there are no residential risk estimates recommended for 
use in the aggregate risk assessment for emamectin.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. The Agency is required to consider the cumulative risks of 
chemicals sharing a common mechanism of toxicity. In 2016, EPA's Office 
of Pesticide Programs released a guidance document entitled Pesticide 
Cumulative Risk Assessment: Framework for Screening Analysis (https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework). This document provides guidance 
on how to screen groups of pesticides for cumulative evaluation using a 
two-step approach beginning with the evaluation of available 
toxicological information and if necessary, followed by a risk-based 
screening approach. This framework supplements the existing guidance 
documents for establishing common mechanism groups (CMGs) and 
conducting cumulative risk assessments (CRA).
    The Agency has utilized this framework for abamectin and determined 
that abamectin along with emamectin form a candidate CMG of the 
avermectin macrocyclic lactones. This group of pesticides is considered 
a candidate CMG because they share characteristics to support a 
testable hypothesis for a common mechanism of action and while there 
are sufficient toxicological data to suggest a common pathway, there 
are not adequate data to establish those key events in a pathway as 
described in the mode of action/adverse outcome pathway (MOA/AOP) 
framework (e.g., lack of dose or temporal concordance of proposed key 
events).
    In 2017, the Agency conducted a screening-level cumulative exposure 
analysis consistent with the guidance described in the cumulative 
screening framework. The screening-level cumulative assessment for the 
avermectin macrocyclic lactones, abamectin and emamectin, indicated 
that cumulative aggregate dietary and residential exposures for 
abamectin and emamectin were below the Agency's levels of concern.
    Based upon updated use information (i.e., new uses), the Agency has 
updated its screening-level cumulative exposure analysis for the 
avermectin macrocyclic lactones, including abamectin and emamectin. 
This updated screening-level cumulative exposure assessment for the 
avermectin macrocyclic lactones, abamectin and emamectin, indicated 
that that cumulative aggregate dietary and residential exposures for 
abamectin and emamectin were below the Agency's levels of concern. The 
screening memo, titled ``Avermectin Macrocyclic Lactones, Abamectin and 
Emamectin. Cumulative Screening Risk Assessment'' can be found in 
docket ID number EPA-HQ-OPP-2018-0088 at http://www.regulations.gov.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. Emamectin did not elicit 
increased fetal sensitivity in developmental toxicity studies in rats 
and rabbits. In the reproductive toxicity study, emamectin produced 
neuronal degeneration in the brain and spinal cord in parental and 
offspring animals at a similar dose level (1.8 mg/kg/day), and no 
increase in quantitative sensitivity was found in the pup with respect 
to the neurotoxicity. However, in the developmental neurotoxicity study 
in rats, there was an increase in both quantitative and qualitative 
sensitivity in the pups as no adverse effect was seen at the highest 
dose tested (3.6/2.5 mg/kg/day) in parental animals, while at 0.6 mg/
kg/day, the pups showed a dose-related decrease in open field motor 
activity at post-natal day 17. Body tremors, hind-limb extension, and 
auditory startle

[[Page 44723]]

were also observed in the high dose pups (3.6/2.5 mg/kg/day).
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1x. That decision is based on the following 
findings:
    i. The toxicity database for emamectin is complete.
    ii. The proposed MOA is interaction with GABA receptors leading to 
neurotoxicity. The clinical signs observed in the emamectin database 
are consistent with the proposed MOA. Following emamectin exposure, 
neurotoxicity has been seen across multiple studies and species of test 
animals. Neurotoxic effects seen in various studies are consistent with 
the MOA of emamectin, and the selected toxicity endpoints and POD is 
protective of the neurotoxic effects in the data.
    iii. As discussed above, the developmental neurotoxicity study 
showed an increase in both quantitative and qualitative sensitivity in 
the pups as indicated by a dose-related decrease in open field motor 
activity at post-natal day 17 at 0.6 mg/kg/day. Body tremors, hind-limb 
extension, and auditory startle were also observed in the high dose 
pups (2.5 mg/kg/day), while no adverse effects were seen in the 
parental animals at the highest tested dose (3.6 mg/kg/day). However, 
the toxicity endpoint and POD (0.25 mg/kg/day) selected for risk 
assessment are protective of the effects seen in the pups.
    iv. There are no residual uncertainties for emamectin with respect 
to the exposure databases. Although the dietary exposure estimates are 
partially refined, anticipated residue estimates for most commodities 
were derived from field trials which are still considered conservative 
since field trials are conducted under maximum use conditions (maximum 
allowed application rate and number of applications, minimum pre-
harvest interval, etc.). Monitoring data were used for apples in the 
acute assessment since apple juice had a significant impact on 
exposure. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to emamectin in 
drinking water. There are no anticipated exposures to residential 
handlers, or for post-application exposure of adults and children. 
These assessments will not underestimate the exposure and risks posed 
by emamectin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to emamectin will occupy 26% of the aPAD for children 1 to 2 years old, 
the population group receiving the greatest exposure.
    2. Chronic risk: Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
emamectin from food and water will utilize 3.4% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
emamectin is not expected.
    3. Short-term risk. A short-term adverse effect was identified; 
however, emamectin is not registered for any use patterns that would 
result in short-term residential exposure. Short-term risk is assessed 
based on short-term residential exposure plus chronic dietary exposure. 
Because there is no short-term residential exposure and chronic dietary 
exposure has already been assessed under the appropriately protective 
cPAD (which is at least as protective as the POD used to assess short-
term risk), no further assessment of short-term risk is necessary, and 
EPA relies on the chronic dietary risk assessment for evaluating short-
term risk for emamectin.
    4. Intermediate-term risk. An intermediate-term adverse effect was 
identified; however, emamectin is not registered for any use patterns 
that would result in intermediate-term residential exposure. 
Intermediate-term risk is assessed based on intermediate-term 
residential exposure plus chronic dietary exposure. Because there is no 
intermediate-term residential exposure and chronic dietary exposure has 
already been assessed under the appropriately protective cPAD (which is 
at least as protective as the POD used to assess intermediate-term 
risk), no further assessment of intermediate-term risk is necessary, 
and EPA relies on the chronic dietary risk assessment for evaluating 
intermediate-term risk for emamectin.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, emamectin is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to emamectin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate methods (Method 244-92-3 and Method 244-92-3, Revision 1) 
are available for the enforcement of tolerances on plants. The methods 
determine residues of emamectin and its regulated isomers and 
degradates/metabolites using high performance liquid chromatography 
with fluorescence detection (HPLC/FLD).
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has established MRLs for emamectin on various commodities 
that are different than the tolerances established for emamectin in the 
United States.

[[Page 44724]]

    The U.S. and Codex residue definitions are not harmonized. The U.S. 
residue definition for emamectin includes the sum of emamectin and its 
metabolites (8,9-isomer) for plants and livestock. The Codex residue 
definition includes only emamectin for plants and livestock 
commodities.
    Codex has MRLs for residues of emamectin on tomato, tomatillo, bell 
pepper, and non-bell pepper, the representative commodities of the 
fruiting vegetable group 8-10 at 0.02 ppm each. The U.S. tolerance at 
0.02 ppm for residues on crop group 8-10 is being harmonized with these 
Codex MRLs.
    Codex has an MRL for residues of emamectin on mustard greens, the 
representative commodity for Brassica leafy greens subgroup 4-16B at 
0.2 ppm. The U.S. tolerance on subgroup 4-16B is being harmonized with 
Codex mustard greens, the representative commodity, at 0.20 ppm.
    Codex has MRLs for residues of emamectin on head lettuce at 1 ppm 
and leaf lettuce at 0.7 ppm. The current U.S. tolerance is 0.1 ppm for 
subgroup 4-16A, which has head lettuce, leaf lettuce, and spinach as 
the representative commodities. EPA is therefore harmonizing the 
tolerance for subgroup 4-16A with Codex head lettuce at 1 ppm.
    Codex has MRLs for apple and pear at 0.02 ppm each. EPA harmonizing 
the tolerance on pome fruit, group 11-10 with these MRLs at 0.02 ppm.
    For tree nut crop group 14-12, the Codex MRLs for residues on the 
representative commodities of this group is 20x lower than the U.S. 
tolerances being established in this rulemaking. Lowering the tolerance 
could cause U.S. growers to have violative residues when following 
label instructions; therefore, EPA is not harmonizing the tolerance 
with the Codex MRLs.
    For all other commodities, Codex does not have established MRLs.

C. Revisions to Petitioned-For Tolerances

    For new uses on globe artichoke, herb subgroup 19A, and cherry 
subgroup 12-12A, the tolerances differ slightly from those proposed by 
IR-4 due to differences in calculating parent equivalents of emamectin 
metabolites from the residue data.
    The currently established tolerance on crop group 11 and the 
proposed tolerance on crop group 11-10 are both at 0.025 ppm. The 
tolerance for pome fruit crop group 11-10 is being established at 0.02 
ppm to harmonize with Codex MRLs on apple and pear.
    The tolerance on Brassica leafy greens subgroup 4-16B is being set 
at 0.2 ppm instead of the proposed level at 0.050 ppm and the tolerance 
on leafy greens subgroup 4-16A is being set at 1 ppm instead of 0.1 ppm 
to harmonize with Codex.
    For the proposed tolerance on fennel, Florence, the commodity 
definition was corrected to be Fennel, florence, fresh leaves and 
stalk.
    For the other commodities and crop groups, the tolerances differ 
from the petitioned-for tolerances due to the use of HED rounding class 
practice.
    The proposed tolerance for emamectin on vegetable, cucurbit, group 
9 at 0.03 ppm is not necessary because the available data support the 
existing tolerance of 0.02 ppm for that crop group.

V. Conclusion

    Therefore, tolerances are established for residues of emamectin, 
including its metabolites and degradates in or on the raw agricultural 
commodities Artichoke, globe at 0.05 ppm; Brassica, leafy greens, 
subgroup 4-16B at 0.2 ppm; Celtuce at 0.1 ppm; Cherry subgroup 12-12A 
at 0.09 ppm; Fennel, florence, fresh leaves and stalk at 0.1 ppm; 
Fruit, pome, group 11-10 at 0.02 ppm; Herb subgroup 19A at 0.4 ppm; 
Kohlrabi at 0.05 ppm; Leaf petiole vegetable subgroup 22B at 0.1 ppm; 
Leafy greens subgroup 4-16A at 1 ppm; Nut, tree, group 14-12 at 0.02 
ppm; Vegetable, brassica, head and stem, group 5-16 at 0.05 ppm; and 
Vegetable, fruiting, group 8-10 at 0.02 ppm.
    Additionally, the following existing tolerances are removed as 
unnecessary due to the establishment of the above tolerances: Fruit, 
pome, group 11 at 0.025; Nut, tree, group 14 at 0.02 ppm; Pistachio at 
0.02 ppm; Turnip, greens at 0.050 ppm; Vegetable, brassica, leafy, 
group 5 at 0.050 ppm; Vegetable fruiting, group 8 at 0.020 ppm; and 
Vegetable, leafy, except brassica, group 4 at 0.100 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). This action does not contain any information collections subject 
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
et seq.), nor does it require any special considerations under 
Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

[[Page 44725]]

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: August 8, 2019.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.505, amend the table in paragraph (a)(1) as follows:
0
i. Add alphabetically the entries ``Artichoke, globe''; ``Brassica, 
leafy greens, subgroup 4-16B''; ``Celtuce''; ``Cherry subgroup 12-
12A''; ``Fennel, florence, fresh leaves and stalk''; ``Fruit, pome, 
group 11-10''; ``Herb subgroup 19A''; ``Kohlrabi''; ``Leaf petiole 
vegetable subgroup 22B''; ``Leafy greens subgroup 4-16A''; ``Nut, tree, 
group 14-12''; ``Vegetable, brassica, head and stem, group 5-16''; and 
``Vegetable, fruiting, group 8-10'';
0
ii. Remove the entries for ``Fruit, pome, group 11''; ``Nut, tree, 
group 14''; ``Pistachio''; ``Turnip, greens''; ``Vegetable, brassica, 
leafy, group 5''; ``Vegetable fruiting, group 8''; and ``Vegetable, 
leafy, except brassica, group 4''.
    The additions read as follows:


Sec.  180.505  Emamectin; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
Artichoke, globe........................................            0.05
Brassica, leafy greens, subgroup 4-16B..................             0.2
Celtuce.................................................             0.1
Cherry subgroup 12-12A..................................            0.09
 
                                * * * * *
------------------------------------------------------------------------
Fennel, florence, fresh leaves and stalk................             0.1
Fruit, pome, group 11-10................................            0.02
 
                                * * * * *
------------------------------------------------------------------------
Herb subgroup 19A.......................................             0.4
Kohlrabi................................................            0.05
Leaf petiole vegetable subgroup 22B.....................             0.1
Leafy greens subgroup 4-16A.............................               1
Nut, tree, group 14-12..................................            0.02
 
                                * * * * *
------------------------------------------------------------------------
Vegetable, brassica, head and stem, group 5-16..........            0.05
 
                                * * * * *
------------------------------------------------------------------------
Vegetable, fruiting, group 8-10.........................            0.02
------------------------------------------------------------------------

* * * * *

[FR Doc. 2019-18386 Filed 8-26-19; 8:45 am]
 BILLING CODE 6560-50-P